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Each CDRL data item should be linked directly to statement of work (SOW) tasks and managed by the program office data manager. Data requirements can also be identified in the contract via special contract clauses (e.g., DFARS), which define special data provisions such as rights in data, warranty, etc. SOW guidance of MIL-HDBK-245D describes ...
Clinical data standards are used to store and communicate information related to healthcare so that its meaning is unambiguous. They are used in clinical practice, in activity analysis and finding, and in research and development. There are many existing and proposed standards and many bodies working in this field.
The statement of work should be directly linked to deliverables shown in the CDRL form. This is done by having each CDRL entry include reference to the SOW paragraph(s) that produces or uses the item, and the SOW text should be clear where it is discussing a deliverable by using the title or parenthesizing the item number (for example, "[A-001]").
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
A data clarification form (DCF) [1] or data query form is a questionnaire specifically used in clinical research. The DCF is the primary data clarification tool from the trial sponsor or contract research organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification. The DCF is part of the data ...
The Fast Healthcare Interoperability Resources (FHIR, / f aɪər /, like fire) standard is a set of rules and specifications for the secure exchange of electronic health care data. It is designed to be flexible and adaptable, so that it can be used in a wide range of settings and with different health care information systems.
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For example, a patient's name, date of birth, or a blood-test result can be recorded in a structured data format. Unstructured health data, unlike structured data, is not standardized. [4] Emails, audio recordings, or physician notes about a patient are examples of unstructured health data.